Breathing Circuit Kits Recalled Due to Assembly Error Affecting Pressure
Percussionaire Corporation is recalling High Frequency Transport Phasitron Breathing Circuit Kits due to assembly errors that can affect pressure output. The defect could impact respiratory support to patients using this device.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. While no deaths or serious injuries have been reported, the assembly error affecting breathing circuit pressure output poses inherent risks to patients dependent on this respiratory support device.
Plain-English summary
Percussionaire Corporation is recalling the High Frequency Transport Phasitron Breathing Circuit Kit (REF: A50605-D) due to an assembly error within the breathing circuit. The manufacturing defect can affect the pressure output delivered by the device, potentially creating a severe impact to patients.
The recall affects 2,145 units distributed across 21 U.S. states: Alabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, Tennessee, Texas, Utah, and Virginia. The affected lot numbers are: WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930, and WO06028.
The recalled product
- Product
- High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- Manufacturer
- Percussionaire Corporation
- Affected units
- 2,145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI: (01)10849436000331/Lot # WO05216
- WO05254
- WO05321
- WO05392
- WO05559
- WO05588
- WO05684
- WO05749
- WO05896
- WO05930
- WO06028
Distribution
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